Phase II study of combination chemotherapy with S-1 plus Avastin in unresectable or recurrent colorectal cancer after failure of prior chemotherapy, including irinotecan and oxaliplatin regimens.
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000002308
- Lead Sponsor
- Translational Research Informatics Center(TRI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
Active infections (e.g., patients with pyrexia of 38'C or higher) Continuous treatment with steroids Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes and hypertension) Patients with electrocardiographic abnormalities, with cardiac disorder that would clinically preclude the execution of the study judged by the investigator. Moderate or severe ascites or pleural effusion requiring treatment Active double cancer prior therapy radiotherapy prior therapy S-1 Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children. Serious drug hypersensitivity or a history of drug allergy Treatment with flucytosine Metastasis to the CNS Thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding (Patients who treated low aspirin therapy(<325 mg/day) can be enrolled.) Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks Severe mental disorder Judged ineligible for participation in the study by the investigator for safety reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease control rate
- Secondary Outcome Measures
Name Time Method Response rate, Progression free survival, Overall survival, frequency of adverese event